Journal of Clinical Oncology, Vol 15, 3100-3110, Copyright © 1997 by American Society of Clinical Oncology
Induction chemotherapy with cisplatin, fluorouracil, and high-dose leucovorin for squamous cell carcinoma of the head and neck: long-term results
JR Clark, PM Busse, CM Norris Jr, JW Andersen, AI Dreyfuss, RM Rossi, MD Poulin, AD Colevas, RB Tishler, R Costello, JW Lucarini, D Lucarini, L Thornhill, M Lackey, E Peters and MR Posner
Division of Clinical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.
PURPOSE: A phase II trial of cisplatin, fluorouracil, and leucovorin (PFL)
induction chemotherapy in patients with locally advanced squamous cell
carcinomas of the head and neck region (HNCA). PATIENTS AND METHODS: One
hundred two patients (stage III/IV, previously untreated) were treated with
induction PFL. Patients with resectable primary tumor site lesions and
clinical complete response (CR) were offered radiotherapy (RT) without
surgery to the primary tumor site. Response, toxicity, local-regional
therapy, survival, and preservation of the primary tumor site were
assessed. RESULTS: Among 279 courses, the overall response rate was 81%.
Nineteen (19%) failed to respond, including three who died during therapy.
Sixty-seven (69%) of 97 with assessable primary lesions had a clinical CR
at the primary tumor site. Pathologic CR was recorded in 46 of 55 (84%)
clinical CR patients who had biopsies performed on the primary tumor site.
Toxicities resulted in unexpected hospitalizations in 19% of cases. After
definitive local- regional therapy, 84 (82%) were disease-free including 71
(69%) with preserved primary tumor site anatomy. With a median follow-up
time of 63 months, the cause-specific, overall (OS), and failure-free
survival (FFS) rates at 5 years are 58%, 52%, and 51%. Local failure
occurred in 29 of 102 (29%) and the local control rate at 5 years was 68%.
CONCLUSION: PFL has significant activity with acceptable toxicity in
patients with advanced disease who have a good performance status.
Preservation of the primary tumor site could be achieved without apparent
loss of local control or survival. Management of neck disease by surgery or
RT must be individualized and separate from management of primary tumor.
Survival compares favorably with similar trials of induction chemotherapy
or chemoradiotherapy.
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